Vaxcyte - Senior Manager, Microbiology Support for Global ASAT

• Degree(s) in Microbiology, Biology, Biochemistry, or related discipline with a minimum of 7+ years of relevant experience for Ph.D., 9+ years for M.S./M.A., or 11+ years for B.S./B.A. Other combinations of education and/or experience may be considered. 7+ years of experience in Pharma / Biotech industry in aseptic manufacturing or microbiology required. Other combinations of education and/or experience may be considered. • Understanding of various analytical methodology principles and experience with GMP release testing. Knowledge of microbial control methods (e.g. Bioburden, Endotoxin, Sterility, Growth Promotion). • Previous experience in analytical method verification, development, validation and transfer is highly desirable. • Experienced leading investigations into microbiological non-conformances (deviations, out-of-specification results), writing and approving Exception Reports (ERs), and driving CAPA (Corrective and Preventive Actions) implementation; displaying excellent organization, problem solving, and strategic planning skills. • Solid understanding of relevant cGMPs, FDA, EU, and ICH regulatory guidelines as applicable to QC operations/aseptic processing/manufacturing sterility assurance, and/or compendial methods (USP/EP/JP). • Able to apply the knowledge and understand/gain in depth understanding of variety of methods in place for components used in Vaxcyte vaccine programs. • Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements “best practices” or leading-edge quality standards. • Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives. • Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process. • Ability to work globally with CMOs in different countries and continents. • Self-starter and resourceful problem solver, able to move up learning curve with some guidance and map out intermediate milestones to achieve personal goals. • Reports to: Senior Director, Global Analytical Sciences and Technology (ASAT) Lead • Reports to: • Location: Open to Remote; San Carlos, CA • Location: